FDA 510(k)

Altaviz Needle Kit

K-Number: K222681 · 2022-12-05

Decision Date2022-12-05

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

Altaviz Needle Kit is a medical device manufactured by Altaviz, LLC. It received FDA 510(k) clearance on 2022-12-05 under approval number K222681. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Altaviz Needle Kit?

Altaviz Needle Kit is a medical device that received FDA 510(k) clearance on 2022-12-05. It is manufactured by Altaviz, LLC. The 510(k) number is K222681.

When was Altaviz Needle Kit approved by the FDA?

Altaviz Needle Kit received FDA 510(k) clearance on 2022-12-05, under approval number K222681.

What company makes Altaviz Needle Kit?

Altaviz Needle Kit is manufactured by Altaviz, LLC.

What is the FDA product code for Altaviz Needle Kit?

The FDA product code for Altaviz Needle Kit is FMI.

Other Devices by Altaviz, LLC

K231261Altaviz Needle Kit II K243322Altaviz Intravitreal Syringe

Related Devices (Code: FMI)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.